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| Name | Class |
|---|---|
| AlvaMed, Inc. | INDUSTRY |
| Bioscience Consulting, Inc. | INDUSTRY |
| Simplified Clinical Data Systems, LLC | INDUSTRY |
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The eShuntâ„¢ System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
This is a prospective, single-center, open label, single-arm pilot study of the eShunt System. The study population consists of patients with post-aneurysmal subarachnoid hemorrhage (SAH) treated for increased intracranial pressure (ICP) resulting in symptomatic hydrocephalus using an external ventricular drain (EVD) to facilitate CSF drainage and who cannot be "weaned" from the EVD following the hemorrhagic event.
The study will be performed a single site with up to 30 subjects who meet the inclusion and exclusion criteria for the study. Subjects will be evaluated every 30 days for the first 90 days following eShunt Implant deployment with standard neurological evaluation appropriate for patients with communicating hydrocephalus. In addition, follow-up will occur at 180 days, 12 and 24 months post-operatively and will include imaging in addition to the standard neurological evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | The Treatment Arm receives the eShunt implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eShuntâ„¢ Implant | Device | The eShuntâ„¢ Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system as a minimally invasive treatment for communicating hydrocephalus. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in intracranial pressure (ICP) | At 36-48 hours following eShunt Implant deployment and with EVD remaining clamped, an ICP assessment that demonstrates: 1) ICP below 20 cmH2O as measured by the EVD with no periods longer than 15 minutes above 20 cmH2O; and 2) No episodes of ICP, measured by EVD, above 25 cmH2O with associated subject symptoms | 36-48 hours following eShunt Implant deployment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects requiring conversion to conventional CSF shunt | Evaluate the need for CSF diversion by conventional CSF shunt insertion within the 24 months following eShunt Implant deployment | 24 months following eShunt Implant deployment |
| Incidence of clinically significant abnormal laboratory test results |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint: serious adverse events (SAEs) | Evaluate for any device or procedure related serious adverse events (SAEs) | 24 months following eShunt Implant deployment |
Inclusion Criteria:
Age > 18
Subject provides Informed Consent (IC)
Post-aneurysmal SAH with Hunt and Hess Grades I-IV with EVD in place with the need for a permanent CSF shunt determined through a failed EVD clamping trial defined as:
Clinical signs and symptoms of communicating hydrocephalus
Neurologically stable without evidence of severe vasospasm
Pre-procedure MRI with gadolinium confirmation of IPS (inferior petrosal sinus) and CPA (cerebellopontine angle) cistern anatomy suitable for eShunt Implant deployment as confirmed by SSC (subject screening committee)
Pre-procedure CT confirmation of no obstruction preventing CPA cistern access at target implant site (e.g., petrous bone) as confirmed by SSC
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro M Lylyk, MD | Clinica Sagrada Familia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClĂnica La Sagrada Familia | Buenos Aires | Ciudad A. de Buenos Aires | C1426B | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30626626 | Background | Heilman CB, Basil GW, Beneduce BM, Malek AM. Anatomical characterization of the inferior petrosal sinus and adjacent cerebellopontine angle cistern for development of an endovascular transdural cerebrospinal fluid shunt. J Neurointerv Surg. 2019 Jun;11(6):598-602. doi: 10.1136/neurintsurg-2018-014445. Epub 2019 Jan 9. | |
| 34862267 |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Prospective, single-center, open-label, single-arm pilot study
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Clinically significant changes from baseline laboratory test results will be summarized |
| 24 months following eShunt Implant deployment |
| Incidence of clinically significant changes from baseline MRI imaging | Clinically significant changes from baseline MRI images will be summarized | 24 months following eShunt Implant deployment |
| Incidence of clinically significant changes from baseline CT imaging | Clinically significant changes from baseline CT images will be summarized | 24 months following eShunt Implant deployment |
| Lylyk P, Lylyk I, Bleise C, Scrivano E, Lylyk PN, Beneduce B, Heilman CB, Malek AM. First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt. J Neurointerv Surg. 2022 May;14(5):495-9. doi: 10.1136/neurintsurg-2021-018136. Epub 2021 Dec 3. |
| 40135887 | Derived | Amllay A, Matouk CC. A Paradigm Shift in Hydrocephalus Management: The Promise of Endovascular Cerebrospinal Fluid Diversion. Cardiol Rev. 2025 Jul-Aug 01;33(4):294-297. doi: 10.1097/CRD.0000000000000886. Epub 2025 Mar 26. |